The Hub Submission Manager is accountable for operational management of regional and/or national regulatory dossiers to designated Health Authorities (HAs). Based within WSR Submission Management, this role sits within a team working to tight, business-critical deadlines within a highly regulated environment. Its primary focus is on allocated region/ countries, with additional responsibility to support other locations through utilization of global tools. On behalf of Worldwide Safety & Regulatory (WSR), to lead and manage logistical and technical aspects, ensuring development and delivery of X-regional, regional and/or national regulatory dossiers - initial application and subsequent lifecycle updates (compliance and maintenance). To execute, through use of standards and tools, designated operational tasks e.g. submission planning, document receipt, translation management, technical build and submittal to HA or via the applicable company country office, conforming to regulatory submission milestones and applicable regulatory obligations. Given the scope of international work, critical features of this role are the ability to successfully interface with multiple cultures and, to recognize and exploit opportunities to use scale, cloning and repurposing dossiers for worldwide markets where feasible.
Responsibilities:
- Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate. Partnering with product teams and/or third-party partners, the incumbent will be responsible for project management of activities, in support of regional and national regulatory submissions component build and delivery.
- Delivering project specific company electronic and paper regulatory submissions. Including co-ordination and execution of solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and ensuring subsequent archival.
- Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional and national markets.
- Actively participate in the definition, investigation and implementation of national, regional and global process efficiencies for paper and electronic submission execution, including the evaluation of current processes.
- Completion of assignments and tasks within a specific task force/project associated with electronic and paper submissions.
- Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
- Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.
- Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
- Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
- Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
Technical Skill Requirements
- B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered
- Demonstrated coordination of activities in a highly regulated environment
- Proven aptitude in project management and logistics
- Demonstration of experience working in a challenging customer service environment
- Proven experience managing or delivering through others in a team environment
- Demonstrated attention to detail
- Relevant experience in electronic submissions build within the Pharmaceutical Industry
- Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers
- Formal training in technical tools
- Knowledge of drug development process
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
- Multi-lingual skills desirable
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferred
- Microsoft Office Suite
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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